Surgical implement detector utilizing a powered marker

ABSTRACT

An apparatus for detecting a surgical implement in human or animal tissue has structure for defining a transmitting zone encompassing a surgical wound in the tissue. A battery powered marker is secured to a surgical implement positioned within the wound. Field generating structure is provided for generating within the transmitting zone an electromagnetic field having a predetermined frequency band. A signal generator generates a signal having a predetermined frequency band. The signal generator is operative to cause the field generating structure to generate the electromagnetic field, providing the marker with signal identity. A detector having an antenna located within the transmitting zone of the marker detects the marker signal irrespective of the marker&#39;s orientation therewithin.

This application is a continuation of application Ser. No. 689,199 filedMay 6, 1991, now U.S. Pat. No. 5,107,862, which, in turn, is acontinuation of application Ser. No. 437,184 filed Nov. 16, 1989, nowabandoned.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a method for detecting a markedsurgical implement such as a sponge, clamp, or a catheter within asurgical wound in human or animal tissue irrespective of its position ororientation therewithin.

2. Description of the Prior Art

During the course of a surgical operation it is frequently necessary forarticles, such as surgical sponges, gauzes, instruments, needles, andthe like, to be placed into a wound cavity. Notwithstanding rigorousprecautions attendant surgical procedures, such items are sometimesinadvertently lost during surgery and remain within the patient. Whenthis happens, the patient can encounter serious consequences, includingpain, infection, intestinal obstruction, and even death. The problem ofretained surgical implements has existed since the earliest days ofsurgery. Procedures conventionally employed to prevent post-surgicalimplement retention include a manual search of the wound by the surgeonprior to closure and a careful accounting for all materials inserted andremoved from the wound. The accounting function is customarily carriedout by the operating room staff, usually the circulating nurse. Despitethese precautionary measures the accidental retention of surgicalimplements continues to occur with disturbing regularity, even inprestigious institutions, and is regarded by surgeons as a majorunsolved problem.

At present, manual search and physical count remain the primary methodsused in detection of retained surgical implements. Most surgicalinstruments are composed of metal, and are easily detectable by x-ray.Sponges have been tagged with radiopaque markers to make them alsovisible on x-ray, but x-rays are not routinely done before completion ofthe operation because of several disadvantages including inconvenience,expense, loss of operative time, and radiation exposure. Postoperativex-rays suffer from some of the same disadvantages. Moreover, even whenpostoperative x-rays are taken, retained items are occasionallyoverlooked; but even if detected, require a second operation to effecttheir removal.

To overcome the difficulty of detecting retained surgical implements, ithas been suggested that the implements be provided with a radioactivetracer. This technique, disclosed by U.S. Pat. No. 2,740,405 to Riordan,is subject to obvious hazards associated with use, storage and disposalof radioactive materials.

It has also been proposed that surgical sponges be marked with aflexible plastic impregnated with either paramagnetic or ferromagneticmaterials in the form of powders. Detection of these marked sponges isaccomplished by a metal detector. This method, taught by U.S. Pat. No.3,422,816 to Robinson et al., provides very small signals difficult todetect over the width of a patient's body. In addition, the Robinson etal. technique provides no discrimination against other metal objects,such as staples which, though present within the surgical wound, areappointed for retention therewithin.

Yet another proposal, advanced by U.S. Pat. No. 3,587,583 to Greenberg,involves use of surgical sponges marked with magnetized particles whosepresence is detectable with magnetodiodes. In practice, however, themagnetic field generated by these particles is too small to be readilydetected by the diodes.

U.S. Pat. No. 4,114,601 to Ables discloses the use of a smalltransponder fixed to a surgical sponge or instrument. This transponderexhibits gyromagnetic resonance at preselected frequencies. Detection isaccomplished by nonlinear mixing of two frequencies impinging upon thetransponder. The gyromagnetic resonance effect disclosed by Ables is ahigh frequency phenomenon, existing at frequencies of the order of about5 gigahertz (5,000,000,000 cycles/sec). These frequencies, known asmicrowaves, are absorbed readily by animal tissue and are, in fact, usedin microwave ovens for cooking. In use of the Ables type transponder,the energy developed goes primarily into heating tissue, rather thanexciting the transponder into gyromagnetic resonance.

SUMMARY OF THE INVENTION

The present invention provides a method and apparatus for accurately andreliably detecting surgical implements within animal or human tissue.The apparatus comprises a detector responsive to the presence, within adetection zone, of a surgical implement to which a marker is secured.The marker is adapted to produce identifying signal characteristicswithin the detection zone of the detector.

Generally stated the apparatus comprises means for defining atransmitting zone encompassing a surgical wound within human or animaltissue. A marker is secured to a surgical implement positioned withinthe wound, the marker being battery powered. The apparatus has a fieldgenerating means for generating an electromagnetic field having apredetermined frequency within the transmitting zone. A signalgenerating means is provided for generating a signal having apredetermined frequency band. The signal generating means is operativeto cause the field generating means to generate the electromagneticfield, providing the marker with signal identity. A detecting meanshaving an antenna located within the transmitting zone of the markerdetects the marker signal irrespective of the marker's orientationtherewithin.

More specifically, the marker comprises a miniature electronictransmitter enclosed within a water-tight case. The case is comprised ofa plastic that remains inert to the body for the duration of thesurgery. The transmitter is comprised of a battery and electroniccircuit, and is adapted to provide a unique identifying signal. Adetector placed within the transmitting zone of the marker is adapted,irrespective of the orientation of such marker, to detect the markersignal and record such detection with visual and/or audio indicators.

Advantageously, the method and apparatus of the invention detectretention of surgical implements with far greater accuracy than methodsand means involving a physical count of implements that enter and exitthe wound. The apparatus is inexpensive to construct, safer for thepatient than postoperative X-rays and avoids risk to the environmentposed by radioactive tracers. Generation of a strong signal is effectedin a highly reliable manner. The signal is more easily distinguishedthan signals generated by magnetic detection systems, and is generatedwithout the heating of tissue caused by microwave detection systems.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood and further advantages willbecome apparent when reference is made to the following detaileddescription of the preferred embodiment of the invention and theaccompanying drawings in which:

FIG. 1 is a block diagram of a surgical implement detector incorporatingthe present invention;

FIG. 2 is a block diagram of a marker suited for use in the detector ofFIG. 1;

FIG. 3 is a block diagram of a marker having an external tail antenna;

FIG. 4 is a diagram of a marker with a reed-switch starting means;

FIG. 5 is a side-view diagram of a wax-spacer starting means;

FIG. 6 is an isometric view of a shrink-tube starting means;

FIG. 7 is a schematic electrical circuit of a nonrechargeable marker;

FIG. 8 is a block diagram of a surgical implement detector incorporatinga coil antenna and a block diagram of a marker having a coil fieldgenerating means.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to the drawings, there is shown in FIG. 1 a block diagram of asurgical implement detector incorporating the present invention. Amarker 20 is secured to a surgical implement 16, such as a sponge,positioned within the wound. The marker 20 has means for defining atransmitting zone 14 encompassing a surgical wound 12 within patient 10.The marker, shown generally at 20 in FIG. 2, consists of a case 28comprised of a material, such as ABS plastic, that will remain inertwithin the wound for the period of the surgery. Within the case 28 ishoused a signal generating means 22, a field generating means 27, astarting means 26, a power means 24, and a recharging means 25. Theconfiguration of field generating means 27 depends on the frequency ofthe signal produced by the signal generating means 22. Below 3 megahertzthe field generating means 27 typically consists of a loop antennacomprised of one or more turns of enamel coated wire. Above 3 megahertzthe field generating means 27 typically comprises a single lead, 2" orless in length, wound within the case and attached at one end to thesignal generating means 22. Alternatively, as shown in FIG. 3, antenna29 can be lengthened and connected through the case as a tail, thusenlarging the transmitting zone 14. In this case, the antenna 29 outsidethe case 28 is comprised of flexible, insulated wire. Upon beingactivated by a signal from the detector, shown generally at 30, thestarting means 26 causes the power means 24 to be connected to thesignal generating means 22 which, in turn, is connected to the fieldgenerating means 27. The resulting field is transmitted within zone 14for a predetermined period of time. The starting means 26 is comprisedof a narrow band receiver 26a tuned to receive said signal from detector30, a timing circuit 26b, and a switch 26c. Timing circuits are wellknown in the art and can be constructed from a type 555 timer, where aresistor and capacitor establish said predetermined time. Switch 26c istypically a simple transistor. The power means 24 is typically arechargeable battery, such as NiCd, periodically refreshed by therecharging means 25. The recharging means 25 is comprised of a coil ofwire connected to an ac to dc rectifier. An external ac source isinductively coupled via a coil to the coil in the recharging means 25.Alternatively, the recharging means 25 is comprised of two externalcontacts through the case 28. Recharging is accomplished by directconnection with an external dc source.

The detector 30 comprises an antenna 32, an electronic switch 31, acontroller 37, an interrogator 38 and its amplifier 35, a signalprocessor 36 and its filtering preamplifier 33, and an indicator 34. Thecontroller 37 acts as a common timing element for the processor 36, theinterrogator 38, and the switch 31. The switch 31 connects the antenna32 to either the processor preamp 33 or the interrogator amp 35 andcontains the appropriate impedance matching elements for eachconnection.

When activated by operating room personnel, the controller 37 causes theswitch 31 to connect antenna 32 to position 39a. The controller nextcauses the interrogator 38 to generate a single signal burst or,alternatively, a periodic signal burst, enhanced by amplifier 35 andtransmitted through switch 31 and antenna 32 to the marker 20, therebyactivating the marker's starting means 26 as described above. The signaltransmitted into zone 14 by the marker 20 is received by the detector 30through its antenna 32, placed within zone 14. The controller nextcauses switch 31 to connect antenna 32 to position 39b. After filteringand amplification by preamp 33 and verification of the received signalby the processor 36, the indicator 34 is activated. The indicator iscomprised of visual and/or aural transducers, such as a light and/or abuzzer. The configuration of the detector antenna 32 depends on thefrequency of the marker signal, as does the marker's field generatingmeans 27. Typically, below 3 megahertz the antenna 32 is a coil andabove 3 megahertz it is typically a single-end lead or whip antenna.FIG. 8 depicts detector 30 having a coil antenna 32 for operation below3 MHz and a marker 20 similarly probided with a coil field generatingmeans 29a.

Alternatively, the power means 24 is not rechargeable but comprises analkaline or lithium battery. The signal transmitted by the marker 20 isof sufficiently long duration, at least 1/f milliseconds where f is thefrequency of transmission in kilohertz, to be detected by the detector30. In this manner, power usage is minimized and battery life ismaximized. The marker construction is simplified by elimination of therecharging means 25.

In a second embodiment of the invention, with reference to FIG. 4,switch 31, interrogator 38 and amplifier 35 of detector 30 areeliminated. With this embodiment, the starting means 26 of marker 20must be manually activated by operating room personnel before the markedimplement 16 is placed within the wound 12. Marker 20 is rechargeableor, alternatively, nonrechargeable as described in the previousembodiment. The starting means 26 is comprised of a normally-closed reedswitch 42. A permanent magnet 44 placed on the outside of the casecauses the switch 42 to be in the open position. Removing,demagnetizing, or reorienting magnet 44 by 90 degrees causes the switch42 to close, thereby energizing the generating means 22. This, in turn,causes marker 20 to transmit a periodic signal. Detector 30, with theelimination of the interrogator 38, works as described in the previousembodiment. Replacing, remagnetizing or reorientating the magnet 44causes switch 42 to open and marker 20 to cease transmitting.

In a third embodiment of the invention, described with reference to FIG.5, the starting means can be activated only once, the activation beingaccomplished by operating room staff prior to the marker's first use.The marker's power means 24 is nonrechargeable and the recharging means25 is eliminated. The starting means 26 is heat-activated and it iscomprised of a spring-loaded battery contact 52 and an insulating waxspacer 54. Alternatively, battery 24 is coated with wax 54, therebyelectrically insulating battery contacts 52 and 56 from battery 24. Thewax 54 is selected to have a melting point, preferably at the standardoperating point of gas sterilizers, approximately 140 degreesFahrenheit. Beeswax and paraffin meet this criterion. Melting of the wax54 causes the spring-loaded or cantilevered contacts 52 and 56 to closeagainst battery 24 energizing the generating means 22, whereby marker 20transmits a periodic signal. Alternatively, as shown in FIG. 6, startingmeans 26 is comprised of a sleeve of heat-shrink tubing 62 placed aroundtwo cantilevered contacts 63. Heat-shrink tubing typically requirestemperatures of 100 degrees centigrade to activate and cannot thereforebe in low temperature gas sterilizers but must be activated by steam orboiling water baths. Heating causes tubing 62 to contract and close thetwo cantilevered contacts 63, causing marker 20 to transmit a periodicsignal. Detector 30 works as described in the previous embodiment.

EXAMPLE I

To further illustrate the present invention, a marker was constructedusing the circuit shown in FIG. 7. Numerous other circuit configurationsare viable, but the circuit specified in FIG. 7 was chosen for itssimplicity. Inductors 76 and 78 were constructed as 1/4 inch diameter byapproximately 1/3 inch length air-core coils each comprised of 10 turnsof 24 gauge magnet wire. Resistor 74 was 200K ohms and capacitor 72 wasa 10 mfd Tantalum. NPN transistor 70 was 2N2222. Battery 24 was a 1.5 Vbutton type EP675 and reed switch 42 was a normally closed type. Thecircuit was placed on a 3/4 inch diameter mounting board and housedwithin a water-tight case having a threaded lid. No antenna lead wasused. A 1 inch bar magnet placed outside the case but parallel to reedswitch 42 was sufficient to open switch 42 causing the marker to beinactive. On removing the magnet, switch 42 closes, causing marker 20 toemit a broad frequency signal having a range from about 15 MHz to 30 MHzand modulated at approximately 1 Hz. The signal was received by anordinary shortwave radio in the aforesaid frequency range at up to 10feet with all orientations of the marker 20, even when the marker 20 wassurrounded on all sides by at least 9 inches of water.

EXAMPLE II

The procedure of Example I was repeated except that the marker used wasprovided with a 3 inch tail antenna as illustrated in FIG. 3. Themarker's transmit zone 14 increased by approximately 50%.

EXAMPLE III

A marker was placed within a human cadaver. The marker used had theconstruction described in Example I, except that the starting means 26was comprised of two contacts manually closed causing marker 20 to emita broad frequency signal having a range from about 15 MHz to 30 MHz andmodulated at approximately 1 Hz. The detector comprised an ordinaryshortwave radio with an insulated wire monopole antenna placed on theoperating table along side the body. All orientations of the marker weredetected.

Having thus described the invention in rather full detail, it will beunderstood that such detail need not be strictly adhered to but thatvarious changes and modifications may suggest themselves to one skilledin the art, all falling within the scope of the invention as defined bythe subjoining claims.

What is claimed is:
 1. An apparatus for detecting a surgical implementin human or animal tissue, comprising:(a) a marker secured to a surgicalimplement adapted to be positioned within a surgical wound, said markerbeing battery powered and including a starting means having a receivermeans for receiving a first signal and a switch connected to saidbattery for activating said marker; (b) field generating means fortransmitting an electromagnetic field having a predetermined frequencyband; (c) signal generating means activated by said starting means inresponse to receipt of a first signal to cause said field generatingmeans to transmit said electromagnetic field, said electromagnetic fieldbeing a second signal that provides said marker with signal identity,and said starting means operating in response to said first signal toclose said switch, connecting said signal generating means with saidbattery; (d) detection means having (i) an interrogator means forgenerating and transmitting said first signal to said starting means,(ii) a signal processor means for receiving said second signal and (iii)an antenna, said antenna being alternately connected to saidinterrogator means and said signal processor means for generating saidfirst signal and receiving said second signal to detect said marker; (e)said field generating means consisting of a coil when said second signalhas a frequency below 3 megahertz and comprising a single end lead whensaid second signal has a frequency above 3 megahertz; and (f) saidantenna being a coil when said second signal has a frequency below 3megahertz and comprising a single end lead when said second signal has afrequency above 3 megahertz.
 2. An apparatus as recited in claim 1,wherein said signal processor means detects and verifies said activationof said marker.
 3. An apparatus as recited in claim 2, wherein saiddetection means further comprises a switch for connecting said antennato either of said signal processor means and said interrogator means. 4.An apparatus as recited in claim 1, wherein said detection means furtherincludes an indicating means for providing an audible or visible alarmwhen said marker is activated.
 5. A method for detecting a surgicalimplement in human or animal tissue, comprising the steps of:(a)attaching a marker to a surgical implement appointed for dispositionwithin a surgical wound, the marker being battery powered; (b)transmitting an electromagnetic field upon receipt of a first signal,said electromagnetic field having a predetermined frequency band; (c)generating said first signal to initiate transmission of saidelectromagnetic field, said electromagnetic field being a second signalthat provides said marker with signal identity; and (d) receiving saidsecond signal to detect said marker.